YAbS

YAbS

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Record category	Entry ID	Status check date	INN	Drug code(s)	Brand name	MAb sequence source	General Molecular Category	Format, general category	Format details	Target(s)	Isotype (Fc)	Light chain isotype	Linker	Ave. DAR	Conjugated moiety	Description	Discovery method	Anticipated events	Most advanced stage of development	Status	Start of clinical phase	Start of first Phase 2	Start of first Phase 3	Indications of clinical studies	Primary therapeutic area	Company	Licensee/Partner	Comments	Factors to discontinuation	Initial approval year	FDA submission date	US approval date	US product name	Company address	Company country	Company region	Company website
Approved	YABS0071	08/16/2023	Tafolecimab	IBI306	SINTBILO	mAb human	Naked monospecific	Full length Ab	None	PCSK9	IgG2	kappa	None	None	None	IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol（LDL-C）uptake	None	None	Approved China	Active	11/27/2017	03/07/2019	12/20/2019	Hypercholesterolemia	Metabolic disorders	Innovent Biologics (Suzhou) Co. Ltd.	None	August 16, 2023 -- Innovent Biologics, Inc. announces that China's National Medical Products Administration (NMPA) has approved SINTBILO® (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. June 13, 2022: Innovent Biologics, Inc. announced that the China's National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection (anti-PCSK-9 antibody, R&D code: IBI306) for the treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia) and mixed dyslipidemia. As of February 2022, three key registration studies of IBI306 have been completed and successfully met the primary endpoint, where CREDIT-2 study for the treatment of Chinese HeFH patients was the first to meet the primary endpoint in August 2021. Innovent plans to communicate with the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) on the submission of a new drug application (NDA) for IBI306 in patients with primary hypercholesterolemia and combined hyperlipidemia. Aug 2021: Innovent Biologics, Inc. announces that the primary endpoint was met in the phase 3 study CREDIT-2 (NCT04759534) of recombinant fully human anti-PCSK-9 monoclonal antibody (R&D code: IBI306, independently developed by Innovent) for the treatment of Chinese heterozygous familial hypercholesterolemia (HeFH). NCT04709536 Phase 3 study not yet recruiting when first posted on Jan 14, 2021. IBI-306, a novel anti-PCSK9 monoclonal antibody was accepted into the National Major New Drugs Innovation and Development Program. As of year end 2019: • Completed a Phase 2 clinical trial in China for non-familial hypercholesterolemia. • Completed first patient dosing in: – a Phase 3 clinical trial in China for heterozygous familial hypercholesterolemia (“HeFH”); and – a pivotal Phase 2b/3 clinical trial in China for homozygous familial hypercholesterolemia (“HoFH”). NCT04289285 Phase 3 study not yet recruiting as of March 3, 2020. NCT04179669 Phase 3 study started recruiting in Dec 2019. NCT04031742 Phase 2/3 study in Homozygous Familial Hypercholesterolemia not yet recruiting as of Sep 23, 2019. NCT03815812 Phase 2 study in Chinese patients with hypercholesterolemia recruiting as of March 2019. NCT03366688 Phase 1 study recruiting as of Aug 2018	None	2023	—	—	Tafolecimab	168 Dongping Street, Suzhou Industrial Park	China	Asia	https://www.innoventbio.com/AboutUs/ContactUs
Approved	YABS0072	03/12/2025	Sintilimab	IBI308	Tyvyt	mAb human	Naked monospecific	Full length Ab	None	PD-1	IgG4	kappa	None	None	None	Immune checkpoint inhibitor	Adimab technology (yeast display)	None	Approved China	Active	09/15/2016	—	09/01/2017	Liver cancer, gastric cancer, solid tumors, non-small cell lung cancer, Esophageal cancer, Hodgkin's lymphoma	Cancer	Innovent Biologics	Eli Lilly	Feb. 23, 2025 -- Innovent Biologics, Inc. announces that the New Drug Application (NDA) for ipilimumab injection (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and granted Priority Review designation in combination with sintilimab as neoadjuvant treatment for resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. June 2022: Approved in China for esophageal squamous cell carcinoma; In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, and recently approved for one additional indication. Two submissions are under review in China. As of June 2022 Lilly SEC filing, In 2020, we obtained an exclusive license for sintilimab injection from Innovent for geographies outside of China. Innovent, with collaboration from us, filed the initial registration of sintilimab injection in the U.S. that the FDA did not approve in its current form and recommended an additional multiregional clinical study be performed. Lilly does not plan to further pursue submission. (https://investor.lilly.com/node/47571/html) March 2022: FDA issues Complete Response Letter (https://investor.lilly.com/news-releases/news-release-details/lilly-announces-complete-response-letter-sintilimab-combination) BLA for approval in NSCLC submitted in March 2021; PDUFA date is March 2022 NCT03794440 Phase 2/3 in liver cancer recruiting as of Feb 2019. Jan 17, 2019: Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, announced today that the first patient has been dosed in a phase III clinical trial (ORIENT-16) that is to evaluate Tyvyt® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection), in combination with capecitabine and oxaliplatin, as first-line treatment for patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma Dec. 27, 2018: Innovent Biologics, Inc. and Eli Lilly and Company ("Lilly") jointly announce today that the co-developed Tyvyt® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL).Sep 2018: Innovent initiated ORIENT-11, a randomized, double-blinded, multicenter, phase III study of sintilimab versus placebo, both in combination with pemetrexed (Alimta®) and platinum-based chemotherapy as first-line treatment for advanced or recurrent ns-NSCLC in China. This study is currently under recruitment and Innovent plans to enroll 378 patients. May 18, 2018: Innovent Biologics Inc. (Suzhou, China) said the State Drug Administration (formerly CFDA) accepted and granted Priority Review to an NDA for sintilimab (IBI308) in April to treat relapsed or refractory classical Hodgkin's lymphoma. The new drug application (NDA) for IBI308 for the treatment of r/r cHL was officially accepted by the Center of Drug Evaluation of the China Food and Drug Administration (CFDA) on April 19, 2018 and was granted the “Priority Review Status” on April 23, 2018. The company also reported preliminary data from the Phase II ORIENT-1 trial evaluating the anti-PD-1 mAb in the indication. Among 96 patients, sintilimab led to an overall response rate (ORR) of 79.2% and a disease control rate (DCR) of 97.9%. According to the company, the results meet the preset statistical criteria. Median duration of response has not yet been reached. Final data will be presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago. Phase 3 NCT03150875 in NSCLC recruiting as of Sep 1, 2017. September, 12, 2016 – Innovent biologics announced today that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with its investigational agent IBI308, a fully human anti-PD-1 antibody, for the treatment of advanced solid tumors. IBI308 has some distinct features that may differentiate it from other commercially available and clinical stage anti-PD1 antibodies. Adimab and Innovent initiated a partnership in 2013 to discover antibodies against multiple targets selected by Innovent. The PD-1 program, which Innovent has partnered with Lilly, was initiated in the spring of 2013.	None	2018	—	—	Sintilimab	9900 Belward Campus Drive, Rockville, MD 20850	United States of America	North America	https://www.innoventbio.com/AboutUs/ContactUs
Approved	YABS0073	09/27/2019	Rituximab	IDEC-C2B8	Rituxan	mAb chimeric	Naked monospecific	Full length Ab	None	CD20	IgG1	kappa	None	None	None	None	None	None	Approved EU, US, Japan, Australia	Active	12/15/1992	11/15/1993	04/15/1995	Non-Hodgkin's B-cell lymphoma	Cancer	Biogen Idec	Schering, Genentech	None	None	1997	02/28/1997	11/26/1997	Rituximab	225 Binney Street, Cambridge, MA 02142, USA	United States of America	North America	https://www.biogen.com/company/contact-us.html
Approved	YABS0074	01/01/2018	Ibritumomab tiuxetan	IDEC-Y2B8	Zevalin	mAb murine	Radioimmunotherapy, RIC	Full length Ab conjugate	None	CD20	IgG1	kappa	None	None	Undisclosed	None	Mouse origin	None	Approved EU, US, Japan	Active	11/24/1992	05/20/1998	02/24/1998	Non-Hodgkin's B-cell lymphoma	Cancer	Biogen Idec	Eli Lilly	None	None	2002	11/01/2000	02/19/2002	Ibritumomab tiuxetan	225 Binney Street, Cambridge, MA 02142, USA	United States of America	North America	https://www.biogen.com/company/contact-us.html
Approved	YABS0075	05/01/2014	Ramucirumab	IMC-1121B	Cyramza	mAb human	Naked monospecific	Full length Ab	None	VEGFR2	IgG1	kappa	None	None	None	VEGF binds to VEGFR-2 (KDR); produced in NS0	Phage display-DYAX	None	Approved EU, US, Japan, Australia	Active	12/15/2004	—	08/15/2008	Gastric Cancer; Adenocarcinoma, Hepatocellular Carcinoma, breast cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, melanoma, Stomach Cancer; Esophageal Cancer, Carcinoma of Urinary Tract; Urethral Carcinoma; Carcinoma of Ureter; Carcinoma of Renal Pelvis	Cancer	Eli Lilly and Company	None	EMA positive opinion given on Sep 26, 2014. Fast track designation, Rolling BLA started in Q1 2013; priority review granted in Oct 2013. First US approval for advanced stomach cancer or gastroesophageal junction adenocarcinoma. Approved in US April 21, 2014	None	2014	08/23/2013	04/21/2014	Ramucirumab	Indianapolis, Indiana, United States	United States of America	North America	https://www.lilly.com/contact-us
Approved	YABS0076	11/24/2015	Necitumumab	IMC-11F8	Portrazza	mAb human	Naked monospecific	Full length Ab	None	EGFR	IgG1	kappa	None	None	None	None	Phage display-DYAX	None	Approved EU, US, Japan	Active	11/15/2004	—	11/15/2009	Non Small Cell Lung Cancer, Metastatic Colorectal Cancer, Solid Tumors	Cancer	Eli Lilly and Company	AstraZeneca, Shire	FDA advisory meeting held July 9, 2015; The FDA is expected to make a decision on Lilly's biologics license application for necitumumab later this year. Fast track designation for non-small cell lung cancer	None	2015	12/02/2014	11/24/2015	Necitumumab	Indianapolis, Indiana, United States	United States of America	North America	https://www.lilly.com/contact-us
Approved	YABS0077	01/06/2018	Cetuximab	IMC-C225, C-225	Erbitux	mAb chimeric	Naked monospecific	Full length Ab	None	EGFR	IgG1	kappa	None	None	None	None	None	None	Approved EU, US, Japan, Australia	Active	11/15/1994	05/15/1995	03/09/1999	Head and neck cancer, colorectal, non-small cell lung cancer	Cancer	Imclone Systems	Eisai, Cambridge Antibody Technology, Basf Pharma	First approved in Switzerland on Dec 1, 2003	None	2003	08/14/2003	02/12/2004	Cetuximab	180 Varick Street, 6th Floor New York, NY 10014, United States	United States of America	North America	https://pitchbook.com/profiles/company/41262-76#overview
Approved	YABS0078	02/06/2025	Tebentafusp	IMCgp100	KIMMTRAK	mAb - source TBD	Bispecific, Immunoconjugate	Fragment fusion	scFv-TCR	CD3, gp100	None	TBD	None	None	T cell receptor	Monoclonal T Cell Receptor Anti-CD3 scFv Fusion Protein; soluble protein comprises a high- affinity T cell receptor (TCR) specific to a peptide sequence from the gp100 antigen, which is presented on melanoma tumour cells by HLA-A2, fused to an anti-CD3 single chain antibody fragment.	None	None	Approved EU, US, Canada, UK, Australia	Active	09/15/2010	10/15/2013	10/16/2017	Uveal melanoma, malignant melanoma	Cancer	Immunocore Ltd	AstraZeneca	FDA approved in Jan 2022 under Priority review based on a late-stage Phase 2 clinical trial (NCT03070392); EC approved in late March or early April 2022. Aug 24, 2021: Immunocore Announces that U.S. Food and Drug Administration and European Medicines Agency accept Biologics License Application and Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma. PDUFA date Feb 23, 2022. April 2021: Immunocore will be working with the FDA to complete submission of a BLA for tebentafusp in the third quarter of 2021. March 10, 2021: Immunocore, a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, announced that four abstracts highlighting the Company’s lead program, tebentafusp, were accepted at the American Association for Cancer Research (AACR) 2021 Annual Meeting, which will be held virtually from April 10-15, 2021. Two abstracts will be presented as oral presentations including, in the plenary session, Phase 3 data comparing tebentafusp (IMCgp100) with investigator’s choice in first line metastatic uveal melanoma (mUM). A second oral presentation will feature data on the kinetics of radiographic response for tebentafusp in previously treated mUM patients. Two abstracts will be poster presentations. Feb 2021: Breakthrough therapy designation granted April 3 2019: Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its development program, the investigation of tebentafusp (IMCgp100) for the treatment of patients who are HLA-A0201-positive with previously untreated, metastatic uveal melanoma (mUM). The pivotal study IMCgp100-202 is a 2:1 randomized study of tebentafusp compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A0201 positive adult patients with previously untreated mUM. The primary endpoint is a comparison of overall survival. Tebentafusp has previously been granted orphan drug designation for uveal melanoma by the US FDA and Promising Innovative Medicine designation under UK Early Access to Medicines Scheme. NCT02889861 terminated due to sponsor decision in Aug 2019. NCT03070392 pivotal Phase 2 study in Uveal Melanoma started in Oct 2017. Collaboration with Lilly to evaluate drug combinations in clinical studies (July 2015). Private company. NCT02535078 Phase 1/2 study in melanoma started in Nov 2015. As per press release dated 0ct 31, 2013, Phase 1 part of clinical study is complete and Immunocore has initiated a Phase IIa study in melanoma to optimize the dosing regimen and maximise the efficacy of IMCgp100. Data expected in 2015. [https://ir.immunocore.com/node/6766/pdf] January 9, 2012, FDA received initial IND submission for IMCgp100‐01. NCT01211262 Phase 1 in melanoma started Sep 28, 2010.	None	2022	06/23/2021	01/25/2022	Tebentafusp, tebentafusp-tebn	92 Park Drive, Milton Park, Abingdon, Oxon, OX14 4RY, UK	United Kingdom	Europe	https://www.immunocore.com/contact-us
Approved	YABS0079	02/06/2025	Mirvetuximab soravtansine	IMGN853	ELAHERE	mAb humanized	ADC	Full length Ab conjugate	None	FR alpha	IgG1	kappa	Sulfo-SPDB, Cleavable linker	3.3 to 4 drugs per mAb	Tubulin inhibitor, DM4 maytansine	M9346A-sulfo-SPDB-DM4 is denoted as IMGN853. DAR range is reported for multiple ADC, including IMGN853 in Ab et al (https://aacrjournals.org/mct/article/14/7/1605/132016/IMGN853-a-Folate-Receptor-FR-Targeting-Antibody). A humanized derivative of MOv19 (denoted M9346A) serves as the antibody moiety of IMGN853.	None	None	Approved EU, US	Active	03/15/2012	01/15/2016	01/15/2017	Epithelial malignancies e.g., ovarian cancer adenocarcinoma	Cancer	AbbVie	None	Nov. 18, 2024: AbbVie announced the European Commission (EC) granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. ELAHERE is the first and only folate receptor alpha (FRɑ)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Feb. 12, 2024: AbbVie announced that it has completed its acquisition of ImmunoGen. Oct. 27, 2023-- ImmunoGen, Inc. announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Mar. 29, 2022-- ImmunoGen, Inc. announced that it has submitted a Biologics License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. PDUFA date is November 28, 2022. NCT04296890 Phase 3 study in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (SORAYA) not yet recruiting as of March 5, 2020. Dec 2019: ImmunoGen announced that FDA has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab). ImmunoGen anticipates enrolling the first patient in SORAYA next quarter and expects top-line data from the study in mid-2021. May 15, 2019-- ImmunoGen, Inc., announced the United States Food and Drug Administration (FDA) has recommended that the Company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer. Mar. 1, 2019: ImmunoGen, Inc. today announced that its Phase 3 FORWARD I trial evaluating the safety and efficacy of mirvetuximab soravtansine compared to chemotherapy in patients with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in either the entire study population or in the pre-specified subset of patients with high FRα expression. NCT03835819 Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer not yet recruiting as of Jul 6, 2019. June 2018: ImmunoGen granted Fast Track designation by the FDA for treatment of patients with, medium to high, FRα+ve platinum resistant ovarian cancer. Jan 2016 ImmunoGen press release: first patient has been dosed in FORWARD I, the Company’s Phase 3 clinical trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer. Mirvetuximab soravtansine is a first-in-class, folate receptor alpha (FRα)-targeting ADC. Mirvetuximab soravtansine is being assessed as a single-agent therapy in the NCT02631876 FORWARD I trial, which is being changed from a Phase 2 to a Phase 3 trial. Mirvetuximab soravtansine is also being assessed in combination regimens in the FORWARD II trial. NCT01609556 recruiting as of June 2015; orphan drug designation for ovarian cancer in US and EU.	None	2022	03/28/2022	11/14/2022	Mirvetuximab soravtansine, mirvetuximab soravtansine-gynx	Waltham, Massachusetts, United States	United States of America	North America	https://www.immunogen.com/
Approved	YABS0080	02/06/2025	Sacituzumab govitecan	IMMU-132, hRS7-SN-38	Trodelvy	mAb humanized	ADC	Full length Ab conjugate	None	TROP-2	IgG1	kappa	CL2A, Cleavable linker	7 to 8 drugs per mAb	Topoisomerase I inhibitor, SN38 (irinotecan active metabolite)	Sacituzumab govitecan-hziy is a Trop-2 directed antibody and topoisomerase inhibitor conjugate, composed of the following three components: a) the humanized monoclonal antibody, hRS7 IgG1κ (also called sacituzumab), which binds to Trop-2 (the trophoblast cell-surface antigen-2); b) the drug SN-38 (irinotecan active metabolite), a topoisomerase inhibitor; c) a hydrolysable linker (called CL2A), which links the humanized monoclonal antibody to SN-38. The recombinant monoclonal antibody is produced by mammalian (murine myeloma) cells, while the small molecule components SN-38 and CL2A are produced by chemical synthesis. Sacituzumab govitecan-hziy contains on average 7 to 8 molecules of SN-38 per antibody molecule. Sacituzumab govitecan-hziy has a molecular weight of approximately 160 kilodaltons.	None	None	Approved EU, US, Australia	Active	06/01/2012	—	10/12/2017	Triple negative breast cancer, metastatic urothelial cancer, Advanced Epithelial Cancers	Cancer	Immunomedics Inc.	Seagen Inc.	Oct 18, 2024: Gilead Sciences is voluntarily withdrawing its drug, Trodelvy, for patients with metastatic urothelial cancer after it failed to meet the main goal in a confirmatory trial. The U.S. Food and Drug Administration had granted accelerated approval to Trodelvy for previously treated patients with metastatic urothelial cancer in 2021, while its continued approval was dependent on results of a confirmatory trial. Approved in EU in Nov 2021. FY 2020 FDA report to congress: 1st cycle 8.0 months; Sponsor 10.5 months; 2nd cycle 4.7 = total time 23.2 PDUFA date June 2, 2020. April 2020: Immunomedics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for sacituzumab govitecan for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting, including patients who are platinum ineligible and have previously received a PD-1 or PD-L1 inhibitor in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. Aug 2019: Resubmission of Biologics License Application on Track for Early Fourth Quarter 2019. January 2019: Complete response letter details CMC issues to be addressed. July 2018: U.S. Food and Drug Administration (FDA) has accepted the Company’s Biologics License Application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. The PDUFA target action date is January 18, 2019. January 8, 2018 --- Immunomedics, Inc., and Royalty Pharma today announced that Immunomedics has agreed to sell tiered, sales-based royalty rights on global net sales of sacituzumab govitecan to Royalty Pharma for $175 million. SG deal placed on hold in March 2017 after a shareholder revolt. Disgruntled investors—led by activist investor venBio—eventually forced through changes to the biotech's board of directors. Feb 2017: Seattle Genetics will be responsible for initiating the Phase 3 clinical trial of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and submitting the initial Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval. The agreement includes the development of additional indications for IMMU-132, including urothelial cancer (UC), small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), which are currently in Phase 2 clinical studies, along with other solid tumor indications being studied in ongoing clinical trials. NCT02574455 Phase 3 study recruiting as of Oct 2017. April 2016: objective durable responses have been achieved with sacituzumab govitecan in a number of patients with advanced, metastatic solid cancers, after failing multiple prior therapies, some including checkpoint inhibitors (CPIs). The antibody-drug conjugate sacituzumab govitecan from Immunomedics has received breakthrough therapy designation by the FDA as a treatment candidate for patients with triple-negative breast cancer who have not responded to other therapies for metastatic disease. Fast track designations for triple-negative breast cancer, non-small cell and small cell lung cancer. Phase 2 study in breast cancer due to start in Aug 2014. Phase 1/2 study NCT01631552 started in Feb 2013; Immunomedics presentation of mid-2012 notes that 'For hRS7-SN-38, we have FDA approval to study in a variety of cancer types…'. US orphan drug designation for small cell lung cancer. As per earnings call on Feb 11, 2014, Immunomedics is discussing outlicensing with potential partners. IMMU-132 has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. Orphan designation in EU for pancreatic cancer. June 1, 2012: Original IND submission to evaluate of sacituzumab (IMMU-132, hRS7-SN38) in patients with advanced epithelial malignancies (IND 115621).	None	2020	05/18/2018	04/22/2020	Sacituzumab govitecan, sacituzumab govitecan-hziy	333 Lakeside Drive Foster City, CA 94404	United States of America	North America	https://www.gilead.com/utility/contact